MAUDE Adverse Event Report: ABBOTT ASSURITY PLUS; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	PM1260
Medical Device Problem Code	Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During an in clinic follow-up, the device was interrogated and revealed the device was in backup operation with power on reset (por).The device was explanted and replaced to resolved the event.The patient was stable and will continued to be monitored.
Additional Manufacturer Narrative
The reported event of pacemaker found in back-up mode was confirmed.Interrogation of the device revealed the device was in backup operation and battery voltage at end of service (eos) when received.A longevity calculation was performed and found the battery depletion was premature based on the device usage.No high current drain sources were found throughout bench and environmental stress testing.Telemetry and pacing functions of the device were tested and found to be normal.The battery analysis by the manufacturer found the battery was normal.The backup operation is consistent with the sudden drop in battery voltage and the cause of premature battery depletion could not be determined.

• Brand Name: ASSURITY PLUS
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 14799459
• Report Number: 2017865-2022-12952
• Device Sequence Number: 17351505
• Product Code: NVZ
• UDI-Device Identifier: 05414734507080
• UDI-Public: 05414734507080
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: PM1260
• Device Catalogue Number: PM1260
• Device Lot Number: 4923570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/25/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown